Recall Z-1173-2007 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Sendx Medical Inc
ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company
| Date | Aug 18, 2007 (initiated Jun 19, 2007) |
| Status | Terminated |
| Reason | Error in the Ca12 calibration value for pCO2 recorded in the cal pack barcode for lot 17323. This error will result in falsely elevated pCO2 results at the high end of the measuring range. |
| Root cause | Other |
| Action | A total of four (4) distributors were sent the recall package (Field Action Notice) by email on 6-29-07. The distributors were provided background information and specific instruction that all Cal packs from lot 17323 should be removed from customer sites and destroyed. The Recall package included a Management Cover for Field Action Notes, a Customer Letter and the Field Action Notice #915-261. All communications regarding field actions associated with this recall were distributed using the Radiometer Field Action Note (FAN) system. |
| Quantity | 69 |
| Distribution | Worldwide Distribution --- USA including state of OH and countries of China, Denmark Latvia, Mexico & Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994346 | ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM Sendx Medical, Inc., Feb 1, 2000 |